(32 days)
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No
The document describes an in vitro diagnostic device for antibiotic susceptibility testing using the agar diffusion method, which is a traditional laboratory technique. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of these technologies.
No.
This device is an in vitro diagnostic tool used for susceptibility testing of bacteria, not for treating diseases or conditions in living organisms.
Yes
The device is used for "in vitro agar diffusion susceptibility testing," which determines the susceptibility of bacteria to an antimicrobial. This type of testing is a diagnostic process to guide treatment.
No
The device description is not found, but the intended use clearly describes a physical disk (HardyDiskTM AST Delafloxacin 5ug (DLX5)) used for in vitro agar diffusion susceptibility testing, which is a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for "in vitro agar diffusion susceptibility testing." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Purpose: The purpose of the testing is to "determine the susceptibility of bacteria to Delafloxacin." This is a diagnostic purpose, providing information about the bacteria to guide treatment decisions.
- Testing Method: The description mentions "agar diffusion susceptibility testing by the agar diffusion test procedure (Kirby-Bauer)," which is a standard laboratory method for determining bacterial susceptibility to antibiotics. This is a typical application for IVDs used in microbiology.
The text clearly indicates that the device is used in a laboratory setting to analyze biological samples (bacteria) outside of the human body to provide diagnostic information.
N/A
Intended Use / Indications for Use
Use of HardyDiskTM AST Delafloxacin 5μg (DLX5) , for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Delafloxacin.
The concentration of Delafloxacin 5pg (DLXS), has been shown to be active against susceptible isolates of the following microorganisms both in vitro and in clinical infections: Staphylococcus aureus (including methicillin-resistant and methicillin-sensitive strains) Staphylococcus haemolyticus Streptococcus pvogenes Streptococcus anginosus Group (including S. anginosus, S. intermedius, S. constellatus) Enterococcus faecalis Escherichia coli Klebsiella pneumoniae Enterobacter cloacae Pseudomonas aeruginosa
The concentration of Delafloxacin 5ug (DLXS), has been shown to be active against susceptible isolates of the following microorganisms for in vitro use: Streptococcus dvsgalactiae Enterobacter aerogenes Haemophilus parainfluenzae Klebsiella oxytoca Proteus mirabilis
HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
Product codes
JTN
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.1620 Antimicrobial susceptibility test disc.
(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and healing, with a double-serpentine design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1. 2017
HARDY DIAGNOSTICS RIANNA MALHERBE LEAD PERFORMANCE STUDIES MICROBIOLOGIST 1430 WEST MCCOY LANE SANTA MARIA CA 93455
Re: K171975
Trade/Device Name: HardyDisk AST Delafloxacin 5 ug (DLX5) Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial susceptibility test disc Regulatory Class: II Product Code: JTN Dated: June 29, 2017 Received: June 30, 2017
Dear Ms. Malherbe:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ribhi Shawar -S For
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171975
Device Name HardyDiskTM AST Delafloxacin 5ug (DLX5)
Indications for Use (Describe)
Use of HardyDisk™ AST Delafloxacin 5μg (DLX5) , for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Delafloxacin.
The concentration of Delafloxacin 5pg (DLXS), has been shown to be active against susceptible isolates of the following microorganisms both in vitro and in clinical infections: Staphylococcus aureus (including methicillin-resistant and methicillin-sensitive strains) Staphylococcus haemolyticus Streptococcus pvogenes Streptococcus anginosus Group (including S. anginosus, S. intermedius, S. constellatus) Enterococcus faecalis Escherichia coli Klebsiella pneumoniae Enterobacter cloacae Pseudomonas aeruginosa
The concentration of Delafloxacin 5ug (DLXS), has been shown to be active against susceptible isolates of the following microorganisms for in vitro use: Streptococcus dvsgalactiae Enterobacter aerogenes Haemophilus parainfluenzae Klebsiella oxytoca Proteus mirabilis
HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | --------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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